About Sylentis

Sylentis is one of the less than 400 companies that has been awarded with the “Madrid Excelente" label.

Madrid Excelente is the guarantee label of the Government of the Community of Madrid for recognizing and certifying quality and excellence in business management, with the aim of encouraging competitiveness in the business world.

The Madrid Excelente seal is not placed on a product or a service; rather it analyzes the overall quality of the company's management. That is, the all around organization is observed from a 360-degree perspective.

Madrid Excelente recognizes companies that are committed to innovation and constant improvement, social responsibility, consumer satisfaction and active contribution to the economic and social development of the region.

Sylentis seeks innovative therapeutic agents based on interference RNA (RNAi), a new technology whose discoverers were awarded the Nobel Prize for Medicine in 2006. Focused primarily on treatments for ophthalmology, it has two compounds in clinical trials for glaucoma and ocular pain associated to dry eye syndrome, and other molecules in pre-clinical development in other areas.

Sylentis’s aim is to exploit RNAi technology to develop innovative pharmaceuticals to treat significant medical needs. Sylentis activities are focused on the development of drugs for glaucoma, ocular pain associated to dry eye syndrome, Chron’s disease, and neurodegenerative disorders. In the short term Sylentis will focus on ocular indications and in particular in glaucoma and dry eye syndrome, indications for which the company has two compounds in clinical trials.

In addition, Sylentis has implemented a quality management system that integrates Good Manufacturing Practice (GMP). For this purpose Standard Operating Procedures (SOPs) have been established to standardize the development process from discovery to manufacturing of drugs. Implementation of this quality system certifies that Sylentis complies with national laws and international GMP guidelines.

In January 2011 Sylentis received the authorization from the Spanish Medicaments Agency (AEMPS) to manufacture investigational drugs. Sylentis received in January 2011 the brand “Madrid Excelente”. This achievement given by The Autonomous Community of Madrid recognizes and certifies a Company for its excellence in management, innovation, social awareness and its contribution to social and economical development of the region.

Sylentis will continue to seek to reinforce this patent portfolio over the time with the filing of patent applications as new inventions are generated in R&D projects.

Stages in the development of therapeutic RNAi products:

Identify therapeutic application. This involves identifying genes responsible for a disease that must be silenced. For this there are two tracks, the physiopathologic-through knowledge of the mechanism of the disease-and drug-mimicking the action of an existing drug.

Design of therapeutic molecule named siRNAs (sort Interference RNAs) targeting the gene silencing identified through bioinformatics tools. As explained, each siRNA was designed from a sequence complementary to the mRNA it is intended to degrade.

In vitro validation and selection of more effective siRNAs. Different siRNAs are tested in cell cultures expressing the gene of interest, in order to determine the most effective compound.

Development of siRNA administration mode. route of administration and dosage formulation.

In vivo validation in appropriate animal models that mimic the disease targeted. The experiment aims to test the efficacy of siRNA in animals and is called experimental proof of concept (EPOC, its acronym in English).

Toxicology studies in animal models. These tests are the regulatory preclinical phase, it will be the basis for requesting permission to begin human trials (IND).

Clinical efficacy and safety study in humans. It is divided into three phases, each with its own objectives and the cost increases exponentially.

The collection and processing of personal data is intended to address your query or suggestion or business proposal by Sylentis or another company PharmaMar Group.

Legitimation and conservation

The legal basis for the treatment of the data is the consent granted by the interested party when providing the data. If you do not provide the necessary information, your request can not be processed. The data will be kept as long as the relationship is maintained and its deletion is not requested and, in any case, in compliance with the statutory limitation periods that apply to it.

Recipients of the transfer of personal data

No cessions of data are foreseen.

Rights of the interested parties

The interested party, and in his case whoever represents him, may exercise his rights of access, rectification, deletion, portability and limitation or opposition rights by means of a written and signed request addressed to:

The interested party has the right to complain before the Control Authority (Spanish Agency for Data Protection www.agpd.es).

How to find us

By car:Sylentis is located in Tres Cantos, 21 Kms from Madrid on the Carretera de Colmenar Viejo (M-607). Take the first turnoff from the motorway towards Tres Cantos (exit 21) and turn left at the second roundabout. At the next roundabout, you will find the entrance to the Parque Tecnológico de Madrid (P.T.M). Once you have passed the security control turn right and take the first road on your right which is Santiago Grisolía. At the end of this road on the right hand side is the Parque Científico de Madrid, inside which one may find Sylentis.

By bus:From the bus station at Plaza Castilla there are several buses which leave for Tres Cantos: bus lines “716”, and “717”. Once in Tres Cantos, the stop is Avenida del Parque or Avenida de Viñuelas, which leaves you close to the main entrance to the Parque Tecnológico de Madrid (P.T.M.).

By train:Trains leave Atocha, Chamartín (next to Plaza Castilla) and other intermediate stations every 15 minutes. One must take train lines “C-10” or “C-7” to Tres Cantos stop. The ride lasts 35 minutes from Atocha and 15 minutes from Chamartin.

Mission

Sylentis is a pharmaceutical company devoted to the research and development of innovative drugs, based on RNA interference technology, for the treatment and prevention of illnesses with unmet needs and with a great impact on present-day society.

Sylentis’s main mission is to provide all health professionals and patients with innovative drugs. We do this by means of personal and technological leadership, and with the aim of enhancing the quality of life of our patients, through innovation in pharmaceutical products.

Vision

It is our wish to become the most highly valued company in the sector by patients, health professionals, collaborators, institutional and community representatives. At the same time, Sylentis intends to continue to grow as a leader in comparison with our competitors.

Through Innovative science and medicine, Sylentis aims to become one of the main companies specializing in the discovery and development of products based on RNAi technology for the treatment of illnesses with great social impact.

In Sylentis we aspire to increase our competivity as a pharmaceutical company, and at the same time boost the therapeutic areas in which we carry out research and develop drugs. Our aim is to assure our capacity to respond to unmet needs in the treatment of illness. To accomplish that with a representative vision of our values and our commitment, will transform us into a reference for health and pharmaceutical assistance.

Sylentis’ main mission is the discovery, development and commercialization of therapies which help to improve patients’ quality of life. All our research projects are centred on pathologies which lack an effective treatment at present. Finding an effective treatment for ophthalmologic pathologies such as glaucoma, inflammatory diseases of a chronic nature or central nervous system illnesses, are a social necessity, as their incidence increases with progressive aging of the population.

Our responsibility in R&D

Sylentis’ research and development is carried out according to existing laws and regulations under the strictest ethical standards. Research with animals tends to reduce the number of subjects used, to substitute this type of experimentation with alternative techniques, and to refine these processes to reduce animal suffering as much as possible.Sylentis participates in European technological platforms (and in their Spanish counterparts) such as “Nanomedicines”, whose objective is to help advance research in the health sciences to solve existing deficiencies in an intelligent manner, and avoid possible security problems associated with potential treatments. These problems may only be solved via close collaboration with other companies within the sector, therefore integration in these platforms is crucial.

All planned clinical trials abide the criteria established by successive editions of the Helsinki Declaration and national and international Bioethical codes (Convention of Oviedo, etc.)